QAengineer13
Quite Involved in Discussions
Hi,
I need some guidance from your previous PMA submission where you have used FDA consensus standard.
1) For the PMA - Do we fill the FORM FDA 3654 or Declaration of Conformity for the particular the standard ( Following the Guidance Doc Recognition and use of consensus standards)
2) If the standard is horizontal and if its set of Requirements and no testing/ acceptance criteria for Pass /fail - ( eg, 62304, Auto11 etc) do I just submit the matrix ( I would really appreciate, if you can share the matrix structure)
Thank you!
I need some guidance from your previous PMA submission where you have used FDA consensus standard.
1) For the PMA - Do we fill the FORM FDA 3654 or Declaration of Conformity for the particular the standard ( Following the Guidance Doc Recognition and use of consensus standards)
2) If the standard is horizontal and if its set of Requirements and no testing/ acceptance criteria for Pass /fail - ( eg, 62304, Auto11 etc) do I just submit the matrix ( I would really appreciate, if you can share the matrix structure)
Thank you!